METHYLPHENIDATE TRANSDERMAL SYSTEM- methylphenidate patch

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

METHYLPHENIDATE (UNII: 207ZZ9QZ49) (METHYLPHENIDATE - UNII:207ZZ9QZ49)

제공처:

PADAGIS US LLC

관리 경로:

TRANSDERMAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Methylphenidate Transdermal System (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Methylphenidate Transdermal System is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product (polyester/ethylene vinyl acetate laminate film backing, acrylic adhesive, silicone adhesive, and fluoropolymer-coated polyester) [see Description (11)] . Methylphenidate Transdermal System is contraindicated during treatment with monoamine oxidase inhibitors, and within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result). Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylphenidate Transdermal System, during pregnancy. Healthcare providers are encouraged to register patients by calling the Nati

제품 요약:

Methylphenidate Transdermal System is supplied in a sealed tray or outer pouch containing 30 individually pouched transdermal systems. See the chart below for information regarding available strengths. *Nominal in vivo delivery rate per hour in children and adolescents when applied to the hip, based on a 9-hour wear period. **Methylphenidate content in each transdermal system. ​Transdermal System Size (cm2 ) Transdermal Systems Per Carton Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]. Do not store transdermal systems unpouched. Do not store transdermal systems in refrigerators or freezers. Once the sealed tray or outer pouch is opened, use contents within 2 months. Apply the transdermal system immediately upon removal from the individual protective pouch. For transdermal use only. See the Patient Counseling Information (17) for specific disposal instructions for unused or expired Methylphenidate Transdermal System.

승인 상태:

New Drug Application Authorized Generic

환자 정보 전단

PADAGIS US LLC
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This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised 10/2023
MEDICATION GUIDE
Methylphenidate (meth-uhl-FEN-i-deyt) Transdermal System, CII
Important: Methylphenidate Transdermal System is for use on the skin
only.
What is the most important information I should know about
Methylphenidate Transdermal System?
Methylphenidate Transdermal System may cause serious side effects,
including:
•
Abuse, misuse, and addiction. Methylphenidate Transdermal System has a
high chance for abuse
and misuse and may lead to substance use problems, including
addiction. Misuse and abuse of
Methylphenidate Transdermal System, other methylphenidate containing
medicines, and
amphetamine containing medicines, can lead to overdose and death. The
risk of overdose and
death is increased with higher doses of Methylphenidate Transdermal
System or when it is used
in ways that are not approved, such as snorting or injection.
•
Your healthcare provider should check your child's risk for abuse,
misuse, and addiction
before starting treatment with Methylphenidate Transdermal System and
will monitor your
child during treatment.
•
Methylphenidate Transdermal System may lead to physical dependence
after prolonged
use, even if taken as directed by your healthcare provider.
•
Do not give Methylphenidate Transdermal System to anyone else. See
"What is
Methylphenidate Transdermal System?" for more information.
•
Keep Methylphenidate Transdermal System in a safe place and properly
dispose of any
unused medicine. See "How should I store Methylphenidate Transdermal
System?" for
more information.
•
Tell your healthcare provider if your child has ever abused or been
dependent on alcohol,
prescription medicines, or street drugs.
•
Risks for people with serious heart disease. Sudden death has happened
in people who have heart
defects or other serious heart disease.
Your child's healthcare provider should check your child carefully for
blood pressure and heart
problems before starting tr

제품 특성 요약

METHYLPHENIDATE TRANSDERMAL SYSTEM- METHYLPHENIDATE PATCH
PADAGIS US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
METHYLPHENIDATE TRANSDERMAL SYSTEM.
METHYLPHENIDATE TRANSDERMAL SYSTEM, CII
INITIAL U.S. APPROVAL: 2006
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
METHYLPHENIDATE TRANSDERMAL SYSTEM HAS HIGH POTENTIAL FOR ABUSE AND
MISUSE, WHICH
CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING
ADDICTION. MISUSE
AND ABUSE OF CNS STIMULANTS, INCLUDING METHYLPHENIDATE TRANSDERMAL
SYSTEM, CAN
RESULT IN OVERDOSE AND DEATH (5.1, 9.2, 10):
BEFORE PRESCRIBING METHYLPHENIDATE TRANSDERMAL SYSTEM, ASSESS EACH
PATIENT’S RISK
FOR ABUSE, MISUSE, AND ADDICTION.
EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE
OF THE DRUG,
AND PROPER DISPOSAL OF ANY UNUSED DRUG.
THROUGHOUT TREATMENT, REASSESS EACH PATIENT’S RISK AND FREQUENTLY
MONITOR FOR SIGNS
AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION.
RECENT MAJOR CHANGES
Boxed Warning
10/2023
Indications and Usage (1)
10/2023
Dosage and Administration (2.1)
10/2023
Dosage and Administration, Disposal of Methylphenidate Transdermal
System (2.3) Removed
10/2023
Dosage and Administration, Maintenance/Extended Treatment (2.4)
Removed
10/2023
Contraindications (4)
10/2023
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.8, 5.13, 5.14, 5.15)
10/2023
Warnings and Precautions, Visual Disturbance (5.9) Removed
10/2023
INDICATIONS AND USAGE
Methylphenidate Transdermal System is a central nervous system (CNS)
stimulant indicated for the
treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
pediatric patients 6 to 17 years of age. (1)
DOSAGE AND ADMINISTRATION
The recommended starting dose for patients new to or converting from
another formulation of
methylphenidate is 10 mg. (2.2)
Methylphenidate Transdermal System should be applie